MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX MESH; SURGICAL MESH

Catalog Number	1190300
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Necrosis (1971); Scar Tissue (2060); Impaired Healing (2378)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex mesh (device 1).Per op notes, ¿ventral hernia was identified.A ventralex mesh (device 1) was placed inferior to fascial edges and secured on all sides using sutures.¿ on (b)(6) 2020 ¿ patient was diagnosed with abdominal wall abscess, mesh erosion, bowel perforation thereby underwent open repair with the removal of mesh (device 1) and implant of phasix mesh (device 2).Per op notes, ¿abscess was drained.There was a perforation of the small bowel with mesh (device 1) eroding into the small bowel.Adhesions were lysed.Loops which were involved with mesh erosion was resected.Onlay phasix mesh (device 2) was placed and secured using suture.¿ on (b)(6) 2020 ¿ patient was diagnosed with necrotic wound thereby underwent debridement of necrotic wound.On (b)(6) 2021 ¿ patient was diagnosed with nonhealing surgical wound thereby underwent scar revision and removal of mesh (device 2).Per op notes, ¿incision was made to remove entire area and to reduce puckering incorporating wound.There was still some phasix mesh (device 2) was curetted off.¿.
Additional Manufacturer Narrative
Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-dec-2019) is considered to be a best estimate.This emdr represents the bd phasix mesh (device 2).An additional supplemental emdr was submitted to represent the bd mesh -ventralex mesh (device 1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23848259
• Report Number: 1213643-2025-01246
• Device Sequence Number: 18527628
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685(17)220128(10)HUDZ2057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: 1190300
• Device Lot Number: HUDZ2057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female